Maintenance Treatment Using Abatacept with Dose Reduction after Achievement of Low Disease Activity in Patients with Rheumatoid Arthritis (MATADOR) - a Prospective, Multicentered, Single Arm Clinical Trial

Shinsuke Yasuda¹, Kazumasa Ohmura¹, Hiroshi Kanazawa², Takashi Kurita¹, Yujiro Kon³, Tomonori Ishii⁴, Satoshi Jodo⁵, Kazuhide Tanimura⁶, Michio Minami⁷, Tomomasa Izumiyama⁸, Takumi Matsumoto⁹, Yoshiharu Amasaki¹⁰, Yoko Suzuki¹¹, Hideki Kasahara¹², Naofumi Yamauchi¹³, Akito Tsutsumi³, Hiromitsu Takemori², Takao Koike¹⁴ and Tatsuya Atsumi¹, ¹Division of Rheumatology, Endocrinology and Nephrology, Hokkaido University Graduate School of Medicine, Sapporo, Japan, ²Department of Rheumatology, Aomori Prefectural Central Hospital, Aomori, Japan, ³Department of Internal Medicine, Takikawa Municipal Hospital, Takikawa, Japan, ⁴Department of Hematology and Rheumatology, Tohoku University Graduate School of Medicine, Sendai, Japan, ⁵Department of Internal Medicine, Tomakomai City Hospital, Tomakomai, Japan, ⁶Hokkaido Medical Center for Rheumatic Diseases, Sapporo, Japan, ⁷Department of Rheumatology and Orthopaedic Surgery, Hokkaido Orthopaedic Memorial Hospital, Sapporo, Japan, ⁸Higashisendai Rheumatic Disease Clinic, Sendai, Japan, ⁹Division of Rheumatology, Kin-ikyo Chuo Hospital, Sapporo, Japan, ¹⁰The Center for Rheumatic Diseases, Tonan Hospital, Sapporo, Japan, ¹¹Izumi Himawari Clinic, Sendai, Japan, ¹²Rheumatology, NTT Sapporo Medical Center, Sapporo, Japan, ¹³Sapporo Kiyota Hospital, Sapporo, Japan, ¹⁴NTT Sapporo Medical Center, Sapporo, Japan

Meeting: 2016 ACR/ARHP Annual Meeting

Date of first publication: September 28, 2016

Keywords: Abatacept, Intervention, multicenter study and rheumatoid arthritis (RA)

Session Information

Date: Monday, November 14, 2016

Title: Rheumatoid Arthritis – Small Molecules, Biologics and Gene Therapy - Poster II

Session Type: ACR Poster Session B

Session Time: 9:00AM-11:00AM

Background/Purpose: Aim of this study was to evaluate the feasibility of maintenance therapy with reduced dose of abatacept (ABT) to 250mg/body after achieving low disease activity (LDA).

Methods: RA patients treated with ABT at 13 sites were enrolled to this prospective, interventional study during the period between March 2013 and March 2015. This study was approved by the ethical committee of Hokkaido University or by each clinical center (UMIN-ID：UMIN000010286). Inclusion criteria were as follows: 1) ages at 20 years or older, 2) under treatment with intravenous ABT at approved doses based on weight range, 3) in LDA (DAS28-CRP < 3.2) at least for 6 months, 4) agreed to join this trial with written informed consent, 5) body weight under 125 kg. Recruited patients were maintained with intravenous monthly ABT at a dose of 250 mg/body (MATADOR protocol). The primary end point was the proportion of the patients continued with MATADOR protocol at 1-year. Secondary endpoints included disease activity measured by DAS28CRP, safety and tolerability. Therapy with reduced dose was discontinued when physicians decided upon disease flare or other reasons, when patients requested, or when severe adverse event(s) occurred.

Results: A total of 57 patients were enrolled fulfilling above criteria and received ABT with MATADOR protocol. Data at 1-year was collected from 53 patients. Age of the patients was 60 ± 11 year (mean, SD) and disease duration was 10.5 ± 9.1 years (mean, SD). Methotrexate was used in 60% (32/53) of the patients at dose of 9.0 ± 3.3 mg/wk (mean, SD). MATADOR protocol was continued for 1-year in 81% (43/53) of the evaluated patients. In 5 patients, ABT was re-increased to the original dose. Resting patients discontinued because of severe adverse events in 2, switching to other bDMARDs in 2, and one dropout. DAS28CRP and remission rate (DAS28CRP < 2.6) was 1.59 ± 0.48 (mean, SD) and 88% (46/53) at the beginning of MATADOR protocol and 1.74 ± 0.70 (mean, SD) and 81% (43/53) at 1-year.

Conclusion: In the early phase II study conducted in Japan, placebo or monthly intravenous ABT at 2mg/kg or 10mg/kg was given for active RA patients despite methotrexate treatment. ACR20 response was significantly better both in the 2mg/kg and 10mg/kg group compared with the placebo (Takeuchi T et al, Mod Rheumatol 2013). Therefore, it would be understandable that 250mg/body of ABT exerts its therapeutic effect in patients once reached remission or LDA with approved doses of ABT. Reducing dose of monthly intravenous ABT (250mg/body) is a realistic choice of maintenance therapy for patients with RA after achievement of remission or LDA with approved doses of ABT.

Disclosure: S. Yasuda, Bristol Myers Squibb, 2; K. Ohmura, None; H. Kanazawa, None; T. Kurita, None; Y. Kon, None; T. Ishii, None; S. Jodo, None; K. Tanimura, None; M. Minami, None; T. Izumiyama, None; T. Matsumoto, None; Y. Amasaki, None; Y. Suzuki, None; H. Kasahara, None; N. Yamauchi, None; A. Tsutsumi, None; H. Takemori, None; T. Koike, Bristol Myers Squibb, 8; T. Atsumi, Bristol Myers Squibb, 8.

To cite this abstract in AMA style:

Yasuda S, Ohmura K, Kanazawa H, Kurita T, Kon Y, Ishii T, Jodo S, Tanimura K, Minami M, Izumiyama T, Matsumoto T, Amasaki Y, Suzuki Y, Kasahara H, Yamauchi N, Tsutsumi A, Takemori H, Koike T, Atsumi T. Maintenance Treatment Using Abatacept with Dose Reduction after Achievement of Low Disease Activity in Patients with Rheumatoid Arthritis (MATADOR) – a Prospective, Multicentered, Single Arm Clinical Trial [abstract]. Arthritis Rheumatol. 2016; 68 (suppl 10). https://acrabstracts.org/abstract/maintenance-treatment-using-abatacept-with-dose-reduction-after-achievement-of-low-disease-activity-in-patients-with-rheumatoid-arthritis-matador-a-prospective-multicentered-single-arm-clinical/. Accessed .

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